Peer-reviewed article
Normal delivery following use of galcanezumab until the first and second trimesters of pregnancy: A report of 2 cases.
Akiyama H, Yamano Y ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This is a clinical case report about two pregnant women with migraines who continued taking galcanezumab (a migraine drug) into early pregnancy and had normal deliveries. Both mothers and babies were healthy at follow-up. The report notes that human safety data for this drug in pregnancy is limited and calls for more monitoring.
Key points
- Two pregnant women aged 34 and 43 received galcanezumab until week 5 and month 5 of pregnancy respectively
- Both delivered healthy baby boys without complications
- Mothers and children remained healthy at subsequent checkups
- Safety of galcanezumab in pregnancy has only been documented in scattered case reports
- Authors recommend continued monitoring of newborns for neurological abnormalities
Limitations
This document reports only two cases and does not evaluate outcomes for child well-being broadly; it focuses on maternal drug safety rather than child health or development. The cases cannot establish whether galcanezumab use in pregnancy is safe for child development or has long-term effects.
Abstract
Rationale Clinical trials have demonstrated the efficacy, rapid action, and safety of calcitonin gene related peptide-related antibody drugs for migraine prevention, and subcutaneous galcanezumab was launched in Japan in April 2021. However, the safety of this drug in pregnant migraine patients has not been demonstrated in humans, with evidence of safety available only from animal studies. We report 2 cases in which subcutaneous galcanezumab was administered continuously until the first and second trimesters of pregnancy, resulting in normal births without any complications for either the mother or child. Patient concerns The cases involved pregnant patients, aged 34 and 43, with long-standing migraines without aura. Diagnoses Migraines without aura. Interventions They were administered galcanezumab until the fifth week and fifth month of pregnancy, respectively. After discontinuation of treatment, the increase in the frequency of the mothers' migraines remained mild. Outcomes Each mother safely gave birth to a baby boy, with acetaminophen administered as needed for the management of headaches. Subsequent checkups showed that both mothers and their children were healthy. Lessons The safety of galcanezumab administration in pregnant women has only been reported in scattered case reports, and further case studies are needed. It is considered necessary to continue to monitor newborns for the development of neurological abnormalities, including higher brain functions.